Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes
Introduction Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechan...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-06-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/6/e051088.full |
| _version_ | 1826852742075777024 |
|---|---|
| author | Ian A Harris Samuel J MacDessi Aziz Bhimani Darren B Chen Ian Harris Michelle Lorimer David Parker Tamara Hooper Richard Boyle Jonathan Mulford Daniel Franks Gregory C Wernecke Durga Bastiras Emma Heath Anthony Leong Brett Fristch David Penn George Kirsh John Limbers Julian Yu Maurice Guzman Peter McEwen |
| author_facet | Ian A Harris Samuel J MacDessi Aziz Bhimani Darren B Chen Ian Harris Michelle Lorimer David Parker Tamara Hooper Richard Boyle Jonathan Mulford Daniel Franks Gregory C Wernecke Durga Bastiras Emma Heath Anthony Leong Brett Fristch David Penn George Kirsh John Limbers Julian Yu Maurice Guzman Peter McEwen |
| collection | DOAJ |
| description | Introduction Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. This study aims to assess the effectiveness of RAS, KA or both to improve clinical outcomes, functional measures, radiographic precision and prosthetic survivorship when compared with current gold standards of surgical care.Methods and analysis A national registry-nested, multicentre, double-blinded, 2×2 factorial, randomised trial will be undertaken with 300 patients undergoing primary unilateral TKA performed by 15 surgeons. The primary outcome will be the between-group differences in postoperative change over 2 years in the mean Knee injury and Osteoarthritis Outcome Score (KOOS-12), comparing first, RAS to CAS as its control, and second, KA to MA as its control. Secondary outcomes will include other knee-specific and general health patient-reported outcome measures (PROMs), intraoperative pressure loads as a measure of soft tissue balance, 6-month postoperative functional outcomes, radiological precision using CT imaging, complications and long-term prosthetic survivorship. The contribution of each patient’s unique coronal plane alignment of the knee phenotype to primary and secondary PROMs will be investigated. OMERACT-OARSI criteria and Patient Acceptable Symptom State outcome score thresholds for the KOOS-12 and Oxford Knee Score will be used in secondary analyses. Primary intention-to-treat and secondary per-protocol analyses will be performed. Statistical analysis will include a generalised linear mixed model for repeated measures for continuous KOOS-12 scores. Kaplan-Meier estimates with adjusted HRs of implant survivorship will be calculated.Ethics and dissemination Ethics approval was obtained from Sydney Local Health District-Royal Prince Alfred Hospital (Approval X20-0494 and 2020/ETH02896 10.24/DEC20). Results will be submitted for publication in a peer-reviewed journal and presented in national, state and international meetings.Trial registration number ACTRN12621000205831. |
| first_indexed | 2024-04-12T15:18:59Z |
| format | Article |
| id | doaj.art-e2daee20db4d4900a4f1c8a2922e911c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-16T17:13:12Z |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-e2daee20db4d4900a4f1c8a2922e911c2025-01-28T09:00:15ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2021-051088Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes 0Ian A Harris1Samuel J MacDessi2Aziz BhimaniDarren B ChenIan Harris3Michelle Lorimer4David Parker5Tamara Hooper6Richard BoyleJonathan MulfordDaniel FranksGregory C Wernecke7Durga Bastiras8Emma Heath9Anthony LeongBrett FristchDavid PennGeorge KirshJohn LimbersJulian YuMaurice GuzmanPeter McEwenUK Heat Illness Advisory Group, London, UK1 Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, AustraliaOrthopaedics, University of New South Wales, Sydney, New South Wales, AustraliaIngham Institute for Applied Medical Research, South Western Sydney Clinical School, UNSW, Sydney, New South Wales, AustraliaSouth Australian Health and Medical Research Institute, Adelaide, South Australia, Australia9 Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, AustraliaSydney Knee Specialists, Kogarah, New South Wales, AustraliaAustralian Orthopaedic Association National Joint Replacement Registry, Adelaide, South Australia, AustraliaSouth Australian Health and Medical Research Institute, Adelaide, South Australia, AustraliaIntroduction Robot-assisted surgery (RAS) and kinematic alignment (KA) are being increasingly adopted to improve patient outcomes in total knee arthroplasty (TKA). There is uncertainty around the individual or combined effect of these concepts compared with computer-assisted surgery (CAS) and mechanical alignment (MA), respectively. This study aims to assess the effectiveness of RAS, KA or both to improve clinical outcomes, functional measures, radiographic precision and prosthetic survivorship when compared with current gold standards of surgical care.Methods and analysis A national registry-nested, multicentre, double-blinded, 2×2 factorial, randomised trial will be undertaken with 300 patients undergoing primary unilateral TKA performed by 15 surgeons. The primary outcome will be the between-group differences in postoperative change over 2 years in the mean Knee injury and Osteoarthritis Outcome Score (KOOS-12), comparing first, RAS to CAS as its control, and second, KA to MA as its control. Secondary outcomes will include other knee-specific and general health patient-reported outcome measures (PROMs), intraoperative pressure loads as a measure of soft tissue balance, 6-month postoperative functional outcomes, radiological precision using CT imaging, complications and long-term prosthetic survivorship. The contribution of each patient’s unique coronal plane alignment of the knee phenotype to primary and secondary PROMs will be investigated. OMERACT-OARSI criteria and Patient Acceptable Symptom State outcome score thresholds for the KOOS-12 and Oxford Knee Score will be used in secondary analyses. Primary intention-to-treat and secondary per-protocol analyses will be performed. Statistical analysis will include a generalised linear mixed model for repeated measures for continuous KOOS-12 scores. Kaplan-Meier estimates with adjusted HRs of implant survivorship will be calculated.Ethics and dissemination Ethics approval was obtained from Sydney Local Health District-Royal Prince Alfred Hospital (Approval X20-0494 and 2020/ETH02896 10.24/DEC20). Results will be submitted for publication in a peer-reviewed journal and presented in national, state and international meetings.Trial registration number ACTRN12621000205831.https://bmjopen.bmj.com/content/12/6/e051088.full |
| spellingShingle | Ian A Harris Samuel J MacDessi Aziz Bhimani Darren B Chen Ian Harris Michelle Lorimer David Parker Tamara Hooper Richard Boyle Jonathan Mulford Daniel Franks Gregory C Wernecke Durga Bastiras Emma Heath Anthony Leong Brett Fristch David Penn George Kirsh John Limbers Julian Yu Maurice Guzman Peter McEwen Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes BMJ Open |
| title | Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes |
| title_full | Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes |
| title_fullStr | Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes |
| title_full_unstemmed | Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes |
| title_short | Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2×2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes |
| title_sort | robotic assisted surgery and kinematic alignment in total knee arthroplasty raskal study a protocol of a national registry nested multicentre 2 2 factorial randomised trial assessing clinical intraoperative functional radiographic and survivorship outcomes |
| url | https://bmjopen.bmj.com/content/12/6/e051088.full |
| work_keys_str_mv | AT roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT ianaharris roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT samueljmacdessi roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT azizbhimani roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT darrenbchen roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT ianharris roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT michellelorimer roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT davidparker roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT tamarahooper roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT richardboyle roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT jonathanmulford roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT danielfranks roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT gregorycwernecke roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT durgabastiras roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT emmaheath roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT anthonyleong roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT brettfristch roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT davidpenn roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT georgekirsh roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT johnlimbers roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT julianyu roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT mauriceguzman roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes AT petermcewen roboticassistedsurgeryandkinematicalignmentintotalkneearthroplastyraskalstudyaprotocolofanationalregistrynestedmulticentre22factorialrandomisedtrialassessingclinicalintraoperativefunctionalradiographicandsurvivorshipoutcomes |